Duns Number:353939929
Device Description: Tissue Punch Guide 3.0
Catalog Number
29144
Brand Name
Nobel Biocare®
Version/Model Number
29144
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 15, 2020
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NDP
Product Code Name
Accessories, implant, dental, endosseous
Public Device Record Key
cf0a2200-bf11-47f3-abfc-3aea3de9f22a
Public Version Date
April 26, 2021
Public Version Number
2
DI Record Publish Date
June 22, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 782 |
2 | A medical device with a moderate to high risk that requires special controls. | 3680 |